1. Public Health Practice vs Research: Implications for Preparedness and Disaster Research Review by State Health Department IRBs David Perlman, Ph.D. Former Director, Human Research Ethics Program, NJDHSS President & Founder, E4 – Eclipse Ethics Education Enterprises, LLC Senior Lecturer, Penn School of Nursing Associate, Penn Center for Bioethics

2. Public Health is Different: Human Subjects Research in Public Health Institutions

3. The Problem
The regulations for the protection of human subjects define research in terms of several key concepts:
Intent
Systematic investigation
Generalizability
At Departments of Health, this definition can prove vexing for determining when activities are research or public health practice.

4. Is it Public Health Practice or Public Health Research?
Two guidance documents are seen as authoritative
Council of State and Territorial Epidemiologists (CSTE) (on left)
Centers for Disease Control (CDC) Guidelines (on right)

5. CSTE Report
Source: CSTE, 2004, p. 14.

6. CDC Guidelines Progression of its argument:
Research is defined as a “systematic investigation…designed to develop or contribute to generalizable knowledge”
Key word: “designed” – “the major difference between research and non-research lies in the primary intent of the activity”
Therefore, the intentionality of the investigator proposing an activity becomes paramount.

7. CSTE Considerations General legal authority Specific intent
Responsibility
Participant Benefits
Experimentation
Subject Selection

8. The Upshot
CDC’s guidelines solely locate the distinction on the specific intent of the activity and therefore on the intentionality of the investigator
Obvious problem: investigators can game the system to avoid IRB review and additional protections for subjects
CSTE Report provides a more nuanced set of considerations to guide decision-making

9. Why is the Distinction Important?
Depending on whether a public health activity is deemed practice or research, a variety of federal and state laws and regulations for the protection of human subjects and their identifiable private information will apply.
Regardless of the determination, public health officials are legally and ethically required to protect the interests of individuals, but the primary focus is on the health of populations.

10. Why Should This Matter?
Some things should not go to the IRB, whereas some should:
“Public health practice activities that are misclassified as research require public health authorities to engage in time-consuming reviews through governmental or private sector IRBs. In some cases, the mere assessment by an IRB, even when expedited, may thwart an activity to the detriment of the public’s health. In other cases, the IRB may require additional protections for persons viewed as human research subjects that defeat public health objectives in principle or design, or for lack of funding” (CSTE, 2004, p. 21).
“Conversely, public health research that is misclassified as practice may allow governmental health authorities to collect and analyze sensitive health data in possible violation of health information privacy interests, or interact with human subjects without complete adherence to research protections to the detriment of the individual participants” (CSTE, 2004, p. 21).

11. Finding the Crucial Balance
Therefore, it is paramount to determine which activities constitute research versus practice
And, the discussion thus far has only focused on what I would term non-preparedness, non-catastrophic public health activities
Analyzing public health activities in this burgeoning area deserves additional consideration

12. Epidemics and Disasters Are Different

13. Preparedness Initiatives and Disaster Research: A Dilemma
Some preparedness initiatives and research activities during, in response to, and after disasters are likely to blur the line between public health practice and research
Current regulations and guidance documents don’t have a mechanism to address the following dilemma:
If it is research, then it must be prospectively approved by an IRB.
Time and a host of additional public health considerations may limit the ability to seek prospective approval of research after disasters
How can the public be assured that public health officials will safeguard their individual rights of protection under the federal regulations governing human subjects research? That is, what mechanism(s) can be used to balance the need to protect individuals and the need for scientific data?
Additional question at end: What training in ethics should be provided to public health officials who will be called on to conduct research in disaster situations?

14. Is This a New or Novel Question?
My research seems to indicate “yes”
There is literature on ethics of research after disasters
My focus is on public health activities that blur the line between practice and research during disaster responses

15. Some Initial Thoughts about Potential Remedies
Re-tool the IRB system such that prospective approval for certain projects is not required
Dr. Emanuel has thought a great deal about how our current system of research protection can be revamped (Emanuel et al., 2004, Annals of Internal Medicine)
Perhaps revamping the system to regionalize or federalize public health research versus practice determinations and IRB review of research projects

16. FDA Regulatory Provisions for Emergency Research
FDA regulations have provisions for emergency research at 21 CFR 50.24:
Prospective informed consent not required
Community consultation before implementation of the project is required
Provision is only for providing an unproven clinical investigative drug, device, or biologic, not for research into public health disasters or epidemics.
According to FDA (2006, personal communication), only about 24 projects have utilized this mechanism since its inception in 1996
This mechanism is not without ethical challenges and detractors (see AJOB 2006 issue)

17. DHHS Regulatory Provisions for Emergency Research
DHHS also enacted the FDA’s provisions in the following guidance document found on the OHRP website.
So there is some justification for such a mechanism.

18. Consensus and Cooperation at the National Level
CSTE
CDC

19. What Should Happen Now?
Only 35 State Departments of Health seem to have IRBs
Every State Department of Health should:
Have an IRB, and
Be knowledgeable about the potential research implications of their preparedness initiatives and have an IRB member ready and available to review disaster projects.

20. Shameless Self-Promotion (Perlman, 2008, Disaster Medicine and Public Health Preparedness 2: )

21. Additional Research and Development on These Topics
Phase I R43 “stimulus” grant to NCI:
Research on how Departments make the distinction
Providing an educational algorithm to assist in making determinations
Establishing a public health and social-behavioral IRB
CDC Contract for public health responder ethics training:
Key informant interviews with veteran responders
Building a learning management system for interactive web-based ethics education
Disclosure: These projects are submitted as small business opportunities through my small ethics education company, E4 – Eclipse Ethics Education Enterprises, LLC.

22. David Perlman, Ph.D. 215-266-9196 dperlman002@yahoo.com
Thoughts or Questions?
David Perlman, Ph.D